Boston Scientific Corp Two Scimed Placemaple Grove Mn 55311 1566 Pma Numberp900056 Supplement Numbers200 Date Received04 11 2022 Decision Date09 02 2022 Product Code Mcx Advisory Committee Cardiovascular Supplement Type135 Review Track For 30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Boston Scientific Corp Two Scimed Placemaple Grove Mn 55311 1566 Pma Numberp900056 Supplement Numbers200 Date Received04 11 2022 Decision Date09 02 2022 Product Code Mcx Advisory Committee Cardiovascular Supplement Type135 Review Track For 30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P900056S200 Boston Scientific Corp.two Scimed Placemaple Grove, MN 55311-1566 PMA NumberP900056 Supplement NumberS200 Date Received04/11/2022 Decision Date09/02/2022 Product Code MCX  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Rotablator™and ROTAPRO™ Rotational Atherectomy System	2022-09-02